Effect of Niaspan on Cholesterol in Men

Study Description

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Brief Summary:

To determine whether 8 weeks of Niaspan treatment increases cholesterol efflux in male subjects with low HDL-C cholesterol when compared to no treatment.

To determine whether 8 weeks of Niaspan treatment increases fecal cholesterol excretion when compared to no treatment.

To determine whether 8 weeks of Niaspan treatment increases the rate of global reverse cholesterol transport when compared to no treatment.

Condition or disease
HDL Cholesterol

Detailed Description:

This will be a single center, open-label, randomized, mechanism of action study consisting of 8 weeks of active treatment preceded by a screening phase from one to 8 weeks and a baseline measurement of parameters of reverse cholesterol transport for 10 days. The population for this trial is 15 non-diabetic men aged 18-70 years. Ten subjects will be low HDL-C male volunteers who will receive aspirin and Niaspan and five subjects will be low HDL-C male volunteers who will receive only aspirin.

Study Design

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Study Type :	Observational
Estimated Enrollment :	15 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Effect of Niaspan on Parameters of Reverse Cholesterol Transport and HDL-C Subclasses in Male Subjects With Low HDL-C Levels
Study Start Date :	December 2007
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	June 2011

Groups and Cohorts

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Group/Cohort
Treatment; Ten subjects will be low HDL-C male volunteers who will receive aspirin and Niaspan
Placebo; Five subjects will be low HDL-C male volunteers who will receive only aspirin.

Outcome Measures

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Primary Outcome Measures :

1. To determine whether 8 weeks of Niaspan treatment increases the following: cholesterol efflux, fecal cholesterol excretion, and the rate of global reverse cholesterol transport, in male subjects with low HDL-C cholesterol when compared to no treatment. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. To measure the longitudinal effects of 8 weeks of Niaspan treatment on percent change in concentration of specific HDL-C sub-fractions when compared to no treatment. [ Time Frame: 8 weeks ]

Biospecimen Retention:   Samples With DNA

Stool, urine, and blood samples will be taken and analyzed as part of the study.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Study will include a total of 15 subjects, non-diabetic men with low HDL-C, defined as <40 mg/dL. Subjects will be aged 18 to 70 years and have a BMI between 18.5-40 kg/m2.

Criteria

Inclusion Criteria:

Subjects meeting the following criteria at the Screening Visit will be eligible to participate:

• Provide written informed consent
• Male
• Age 18 to 70 years
• BMI 18.5-40 kg/m2
• HDL-C values <40 mg/dL
• Triglyceride value 150-500 mg/dL.
• Good health based on medical history, physical examination and laboratory safety tests performed at the screening visit or prior to initial dose of study medication.
• No clinically significant abnormality on ECG performed at the screening visit or prior to initial dose of study medication.
• Non-smoker and no other use of nicotine containing products for at least 6 months and does not plan to begin smoking during the course of the study.
• Dietary or nutritional remedies including plant sterol containing products (i.e. Benecol, SmartBalance, etc) of any sort for at least 2 weeks prior to and throughout the study.
• Willing to avoid the use of lipid modifying medications (excluding statins) such as the fibrates, cholestyramine, fish oil, and ezetimibe within 8 weeks prior to and during the study.
• Avoidance of extreme change of physical activity from screening through the follow-up period.

Exclusion Criteria:

Subjects are excluded from participation in the study if any of the following criteria apply:

• History of intolerance to Niacin or Niaspan.
• Treatment with Niacin or Niaspan in the past 3 months (Multivitamin use with non-pharmacologic doses of Niacin - less than 500mg per day - is allowed).
• History of stroke, chronic seizures, or major neurological disorder.
• Significant emotional problems or a history of clinically significant psychiatric disorder.
• Bleeding diathesis or intolerance to aspirin.
• Anemia as defined as a hematocrit < 25%.
• History of gastritis, bleeding gastric or duodenal ulcers.
• History Type 1 or Type 2 diabetes, or fasting plasma glucose >125 mg/dL at screening or 75 gm OGTT with 2 hour glucose >140mg/dL.
• History of illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk through participation.
• History of ileal bypass, gastric bypass, or other condition associated with malabsorption.
• Abnormal thyroid function tests.
• AST or ALT > 1.5x the upper limit of normal.
• Active or recent gastrointestinal condition such as gastroenteritis, irritable bowel syndrome, chronic constipation, or diarrhea which may affect bowel movements.
• History of plant sterol storage disease or a history of intolerance to plant sterols or plant sterol containing products.
• History of neoplastic disease (i.e. leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment. Exceptions include adequately treated non-melanomatous skin carcinoma, and other malignancies that may have been treated successfully >10 years prior to the screening visit with no evidence of recurrence.
• Excessive alcohol consumption defined as > three glasses of alcoholic beverages or distilled spirits per day. *** Must avoid excessive alcohol consumption throughout study.
• Currently using psyllium or other fiber based laxatives, phytosterol margarines, and/or over the counter (OTC) treatments that are known to affect serum lipids and has NOT been treated with a stable regimen for > 6 weeks prior to screening (Visit 1) or the subject DOES NOT agree to continue this regimen for the duration of the clinical trial.
• Regular user of illicit drugs or history of drug abuse (including alcohol) within the previous 2 years.
• Use of anabolic agents.
• Any condition or therapy which, in the opinion of the investigator, poses a risk to the subject
• Use of any investigational drug within 30 days before screening

Contacts and Locations

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Locations

United States, Texas
Diabetes and Glandular Research Associates
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

KineMed

Investigators

Study Director:	Scott Turner, PhD	KineMed, Inc.

More Information

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Responsible Party:	Drina Boban/ Clinical Studies Director, KineMed, Inc.
ClinicalTrials.gov Identifier:	NCT00765284 History of Changes
Other Study ID Numbers:	KM-12
First Posted:	October 2, 2008
Last Update Posted:	June 30, 2011
Last Verified:	June 2011

Keywords provided by KineMed:

HDL; RCT; Cholesterol

Additional relevant MeSH terms:

Niacin; Nicotinic Acids; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents	Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs